ARTHROCARE PARALLAX CONTOUR VERTEBRAL AUGMENTATION DEVICE

About This 510(k) Submission

K110183 is an FDA 510(k) clearance for the ARTHROCARE PARALLAX CONTOUR VERTEBRAL AUGMENTATION DEVICE, a Cement, Bone, Vertebroplasty (Class II — Special Controls, product code NDN), submitted by Arthrocare Corp. (Sunnyvale, US). The FDA issued a Cleared decision on February 16, 2011, 26 days after receiving the submission on January 21, 2011. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3027.